FDA WARNING_LETTER - Elite Massagers, LLC. - April 14, 2015

An FDA inspection of Elite Massagers, LLC. and Y&G Group, LLC. in Richardson, Texas, from March 25 to April 14, 2015, revealed significant violations regarding unapproved devices, medical device reporting (MDR), and quality system (QS) regulations.

Several products were deemed adulterated and misbranded. The Elite Massager Multi-Pro was modified with eight massage modes, exceeding its cleared six modes under K121719, constituting a major change without new premarket notification. The Elite Massage Belt and Elite Massage Shoes were marketed without prior marketing approval or clearance. Elite Massager Mono and Elite Massager Multi were found with "Pressure Point Charts" promoting unapproved therapeutic claims beyond their TENS/PMS indications, despite the firm's prior commitment to remove them. Additionally, these massagers were marketed for "massaging" indications, which is outside their 510(k) clearance. Elite Heat packs were marketed for uses like myalgia and fibromyalgia, exceeding the exemption limits for hot/cold disposable packs (21 CFR 890.5710) and reaching temperatures (130°F) higher than legally marketed devices (41.5°C).

The firm's MDR procedures were inadequate, lacking definitions for reportable events, standardized review processes, and instructions for timely transmission of complete reports, including 5-day and supplemental reports. The QS regulation violations